Statistics in Drug Research: Methodologies and Recent Developments

✍ Scribed by Shein-Chung Chow, Jun Shao

Publisher: CRC Press
Year: 2002
Tongue: English
Leaves: 372
Series: Chapman & Hall/CRC Biostatistics Series
Edition: 1
Category: Library

No coin nor oath required. For personal study only.

✦ Synopsis

Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this book outlines important statistics applications for each stage of pharmaceutical development to ensure the valid design, analysis, and assessment of drug products under investigation and establish the safety and efficacy of pharmaceutical compounds. Coverage include statistical techniques for assay validation and evaluation of drug performance characteristics, testing population/individual bioequivalence and in vitro bioequivalence according to the most recent FDA guidelines, basic considerations for the design and analysis of therapeutic equivalence and noninferiority trials.

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